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Amgen logo
Amgen

Founded in 1980, Amgen (short for Applied Molecular Genetics) is a biotechnology firm focused on developing human therapeutics. As an employer, Amgen has been d

Study Start-up Manager

Location

United States

Posted

104 days ago

Salary

$122.2K - $150.4K / year

Seniority

Senior

Bachelor Degree5 yrs expExperience acceptedEnglish

Job Description

Study Start-up Manager

Amgen

• Drive the planning and execution of clinical study start-up activities • Ensure trials are launched efficiently, compliantly, and to the highest quality standards • Lead the planning and delivery of clinical study start-up activities from global to local • Own and manage study start-up plans and milestones • Act as the primary point of contact for cross-functional start-up teams • Identify, assess, and mitigate risks proactively • Partner closely with Study Delivery Leads, managers, and local teams • Apply strong operational and regulatory knowledge to enable high-quality execution • Manage internal resources and external suppliers • Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices

Job Requirements

  • Pharma and clinical trial processes and operations expertise
  • Experience leading and managing global teams
  • Project management experience
  • Doctorate degree OR Master’s degree and 3 years of clinical execution experience OR Bachelor’s degree and 5 years of clinical execution experience OR Associate’s degree and 10 years of clinical execution experience OR High school diploma / GED and 12 years of clinical execution experience
  • Experience directly managing people or leading teams, projects, programs, or directing the allocation of resources
  • Preferred: 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience
  • Experience working in global clinical trial teams across multiple geographies
  • Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management
  • PMP Certification

Benefits

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • A discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

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